A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

A Phase 2 Randomized, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults With Celiac Disease to Assess the Effect of Nexvax2 on Symptoms After Masked Gluten Food Challenge

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.

Inclusion Criteria:

• Adults 18 to 70 years of age (inclusive)
• History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
• Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
• Willingness to consume a moderate amount of gluten
• Able to read and understand English
• Worsening of GI symptoms in response to an oral gluten challenge
• HLA DQ 2.5 positive

Exclusion Criteria:

• Unwilling or unable to perform self-injections
• History of inflammatory bowel disease and/or microscopic colitis.
• Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
• Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
• Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
• Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
• Females who are lactating or pregnant
• Receipt of any vaccine within 1 week prior to planned first day of the treatment period.